Integrated testing device

ABSTRACT

An integrated testing device and method are disclosed. The device includes an integral reservoir for a test fluid, and an actuator, so that the test fluid can be dispensed to facilitate the test.

TECHNICAL FIELD

The present invention relates to devices and methods for providing testsrelating to bodily fluids such as blood, and particularly to the deviceswhich facilitate such testing.

BACKGROUND OF THE INVENTION

Systems for performing relatively immediate tests, assays or diagnoseswith relative ease are known. However, performing these relativelyimmediate tests, assays or diagnoses can require complicated instructionand multiple devices. The present invention is not concerned with thespecific biochemical or chemical tests to be performed, but rather withthe device and mechanical systems which house and contain the teststrips or similar components. For example, the present invention may beapplied with a lateral flow or similar type of rapid test.

In a typical conventional home or point of care test, for example, theuser is presented with a collection of components, including the testdevice itself, a separate lancet, blood collection receptacles, acontainer of buffer or other test fluid, an adhesive bandage, cleaningwipes, and possibly further components. The user is expected to follow avery precise sequence of steps, typically including cleaning the site,operating the lancet, obtaining a blood sample and delivering it to theprecise place required, applying a buffer solution at the right time andplace and in the correct volume, and reading the test result andinterpreting it.

Many tests are performed either as infrequent or one off procedures, sothat the user does not become proficient through regular use. Proceduresperformed at point of care are carried out generally by skilledoperators, but again specific tests may be performed infrequently. Insuch situations it would be advantageous if the test device could betterfacilitate simple, reliable and accurate operation.

It is an object of the present invention to provide a test device, whichis capable of encouraging better compliance with at least some of therequired test processes.

SUMMARY OF THE INVENTION

In a broad form, the present invention provides a test unit including anintegrated reservoir for buffer or other test fluid. Upon operating anactuator, the fluid is dispensed so that it contacts the test component.

According to one aspect, the present invention provides an integratedtesting device comprising:

-   -   a test component;    -   a reservoir adapted to contain a test fluid; and    -   a fluid delivery actuator, wherein operation of the fluid        delivery actuator causes the test fluid to be released from the        reservoir so as to contact the test component.

According to another aspect, the present invention provides a method forconducting a test on a sample of a bodily fluid, comprising the steps ofproviding a testing device including a reservoir containing a testfluid, and further including a test component, wherein a sample of thebodily fluid is placed on the test component, and a quantity of testfluid is discharged from said reservoir onto the test component, thedischarge being either before or after the sample is placed on the testcomponent, so that the test component can thereby conduct the test.

According to a further aspect, the present invention provides anintegrated testing device, comprising a support structure, a reservoiradapted to contain a test fluid, and a fluid delivery actuator, thedevice being adapted to receive a test component in said supportstructure, so that operatively, once a test component is received, thefluid delivery actuator can selectively cause the test fluid to bereleased from the reservoir so as to contact the test component.

Accordingly, implementations of the present invention allow for a testdevice to include a controlled volume of test fluid, such as a buffer,which can be dispensed within the test device itself, and to the correctsite within the test device. This removes a significant source ofpotential error by a user, and increases the likely compliance withprocedures and accuracy of the use of the test device.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments will now be described by way of example only, withreference to the accompanying drawings in which:

FIG. 1 shows an isometric view of one embodiment of the system;

FIG. 2 shows a side view of the embodiment of FIG. 1;

FIG. 3 shows a second side view of the embodiment of FIG. 1;

FIG. 4 shows a third side view of the embodiment of FIG. 1;

FIG. 5 shows a fourth side view of the embodiment of FIG. 1;

FIG. 6 shows an isometric view of a second embodiment of the presentsystem;

FIG. 7 shows a top view of the embodiment of FIG. 6;

FIG. 8 shows an isometric view of a third embodiment of the presentsystem;

FIG. 9 shows a side view of the embodiment of FIG. 8;

FIG. 10 shows a second side view of the embodiment of FIG. 8;

FIG. 11 shows a third side view of the embodiment of FIG. 8;

FIG. 12 shows a fourth side view of the embodiment of FIG. 8;

FIG. 13 shows a top view of a fourth embodiment of the present system;

FIG. 14 shows a side view of the embodiment of FIG. 13;

FIG. 15 shows a bottom view of the embodiment of FIG. 13;

FIG. 16 shows a top view of a fifth embodiment of the present system;

FIG. 17 shows an isometric view of the embodiment of FIG. 16;

FIG. 18 shows an isometric view of the embodiment of FIG. 16 in a closedposition;

FIG. 19 shows a top view of a sixth embodiment of the present system;

FIG. 20 shows a perspective view of the embodiment of FIG. 19;

FIG. 21 shows a cross sectional view of the embodiment of FIG. 19;

FIG. 22 shows a perspective view of a seventh embodiment of the presentsystem in a first position;

FIG. 23 shows a top view of the embodiment of FIG. 22;

FIG. 24 shows a cross sectional view of the embodiment of FIG. 22;

FIG. 25 shows a perspective view of the embodiment of FIG. 22 in asecond position;

FIG. 26 shows a top view of the embodiment of FIG. 22 in a secondposition;

FIG. 27 shows a perspective view of an eighth embodiment of the presentsystem in a closed position;

FIG. 28 shows a perspective view of the embodiment of FIG. 27 in use;

FIG. 29 shows a perspective view of the embodiment of FIG. 27 in use;

FIG. 30 shows a perspective view of a ninth embodiment;

FIG. 31 shows as partly disassembled view of the embodiment of FIG. 30;

FIG. 32 shows a detailed view of part of FIG. 31;

FIG. 33 shows a perspective view in section of the embodiment of FIG. 30in a ready position;

FIG. 34 shows a perspective view in section of the embodiment of FIG. 30in a buffer release position;

FIG. 35 shows a perspective view of a tenth embodiment;

FIG. 36 shows a view in section of the embodiment of FIG. 35;

FIG. 37 shows a perspective view of a sachet for use with an eleventhembodiment;

FIG. 38 is a view illustrating assembly of the sachet of FIG. 37;

FIG. 39 is an exploded view of the eleventh embodiment illustratingassembly of the sachet into the housing;

FIG. 40 shows a perspective view of the buffer sachet assembly of FIG.39;

FIG. 41 shows a cross sectional view of the embodiment of FIG. 40;

FIG. 42 is a perspective view, partly cut away, illustrating a twelfthembodiment;

FIG. 43 is view similar to FIG. 42 but in a second position;

FIG. 44 shows a perspective view similar to FIG. 42, but not cut away;and

FIG. 45 shows a view similar to FIG. 44, but in a second position.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be described with reference to a number ofpossible embodiments. It will be appreciated that the present inventionis capable of being implemented in numerous ways, in addition to theexamples provided. The embodiments are intended as illustrative, and arein no way limitative of the inventive concept or its possibleimplementations. Further, it will be understood that the features ofdifferent embodiments may be formed into different combinations, oradded together, in order to provide further implementations of thepresent invention.

Referring to FIGS. 1 through 5, disclosed is a composite diagnosticsystem (10). The diagnostic system (10) comprises a support member (20)which is made up of a body (21) in the form of a housing having sixsides. The body (21) comprises top face (22) bottom face (23) and sides(24).

Embodiments described are in a form which is sized to be hand-held by auser. However a person skilled in the art will be aware that the systemmay be designed for use on a table top or any alternative positioningand orientation and later embodiments are described for table top use.

The diagnostic system further comprises an integrated lancet (28). Theintegrated lancet is positioned in one side (24) of the body (21). Theintegrated lancet (28) is positioned such that a finger pad aperture(29) is adjacent the integrated lancet (28). The integrated lancetcomprises a lancet tip (not illustrated) which is moveable between arest position in which the lancet is enclosed within the body (21) andan actuated position in which the lancet tip extends from the body. Inthe actuated position, the lancet tip extends from the body such that afinger positioned in the finger pad aperture is pierced by the lancetupon the lancet moving between the rest position and the actuatedposition.

In use, activation of the lancet between the rest position and theactuated position occurs through depression of a lancet activator (30)which is positioned on the body. Contact with the lancet activator (30)moves the lancet tip into the finger pad aperture (29) to pierce afinger or alternative body part positioned in that aperture.

Upon a user's finger being pierced by the lancet, the user or clinicianmoves the user's finger over the blood collection window (32) and bodilyfluid, in this case blood, is collected at fluid collection window (32).The fluid collection window (32) is positioned proximal to the aperture(29) to allow a user to easily move the pierced finger between theaperture (29) and the fluid collection window (32) without depositingfluid other than in the window.

The diagnostic system further comprises a physiologically acceptablesolution such as a buffer for supporting the blood or other bodilyfluid. A solution delivery actuator (35) is positioned on the diagnosticsystem. Contact with the solution delivery actuator releases the buffersolution from an internal reservoir and delivers it to a test materialincorporated into the diagnostic system (10). The test material maycomprise a lateral flow test strip, a vertical flow test strip, solidphase test material, agglutination test material, a cartridge or reagenttube or any element which incorporates a reagent adapted to be mixedwith the bodily fluid, a card incorporating a fluid sample retentionmaterial, an assay, a test strip or an integrated electrical circuit orany material adapted for retaining a sample and allowing a diagnostictest to be performed thereon.

The present invention is not principally concerned with precisely thenature of the test itself, but with the mechanical structures andcomponents which allow an effective and accurate test to be made.Accordingly, any kind of chemical, biochemical, microbiological,genetic, biological or other test may be performed using implementationsof the present invention, suitably modified to meet to the particularrequirements of those tests. Whilst many of the examples are concernedwith test strips, it will be understood that this is merely conventionaland any form or shape of test component may be used. The term testcomponent is to be accordingly understood in the broadest sense.

Similarly, whilst the examples are principally in the context of blood,any other fluid or other sample, for example urine, seminal fluid,plasma, wound discharges, or other materials could be utilised intesting according to the present invention.

The diagnostic system further includes a results window (41) which ispositioned for easy viewing of the results of any diagnostic testperformed.

An alcohol swab locator (45) in the form of a depression in whichalcohol swabs and dry wipes can be inserted is positioned in side (24).The depression (45) is covered by a seal (46) such as a foil seal orplastic seal.

An adhesive bandage locator (48) is positioned in a further side of thediagnostic system. The adhesive bandage locator, is in a form of adepression which fits adhesive bandages such as Band-Aids™

The sides of the diagnostic system (10) are labelled with indicia (72)indicating the order in which the sides are to be used. This simplifiesthe process of utilizing the system and allows an at home user toconfidently proceed through the necessary steps. The positioning of thefinger pad aperture (29), the fluid collection window (32), the solutiondelivery actuator (35) the alcohol swab locator (45) and the adhesivebandage locator (48) allow for a simple movement through the steps ofthe process. This allows for an intuitive movement about the surfaces ofthe system (10). Thus the lancet activator (30) is adjacent the fluidcollection window (32) which is adjacent the solution delivery actuator(35) which is positioned adjacent the adhesive Band-Aid™ locator (48)allowing for sequential motion about the system (10) when following thesteps in the order indicated by the indicia (72).

In a second embodiment of the present diagnostic system, shown in FIGS.6 and 7, the diagnostic system (50) comprises a body (51) in the form ofa substantially H-shaped housing.

In the illustrated form, the housing includes an integrated lancet (52)which extends substantially through the housing (51). The lancet (52) ismoveable between a rest position in which the lancet tip is enclosedwithin the body (51) and an actuated position in which the lancet tipextends from the body (51). The lancet (52) is actuated by a lancetactivator (53) positioned at one end of the body (51).

While the illustrated form includes a membrane penetration element inthe form of a lancet, persons skilled in the art will be aware that the,membrane penetration element could be any piercing, slicing, cutting,puncturing or pricking element which allows a user to penetrate amembrane such as the skin to allow a fluid sample to be released.

The diagnostic system further comprises a blood collection window (54)in which a user places their pricked finger in order to collect bloodexpelled from the finger after the lancet pierces the finger. The bloodcollection window is positioned in line with a test material which isincorporated into the diagnostic system (50). A receptacle for buffersolution (55) is positioned on the diagnostic system (50). Thereceptacle (55) is in the form of a sachet of buffer solution which canbe manually added to the blood in the blood collection window (54).

The lateral flow test strip (56) extends across one portion of thediagnostic system such that the blood collection window (54) and aresults window (57) are both positioned above the lateral flow teststrip (56). Buffer (55) is added to a blood collection window (54) andresults appear in the results window (57).

In use, a user will peel foil (60) positioned over an alcohol swab anddry wipe (61 and 62). They will then clean their finger with the alcoholswab (61) and dry it with the dry wipes (62). The user will then placethe pad of the finger against the integrated lancet (52) at point (63).

Lancet activation is brought about by contact with button (53). In theillustrated form, lancet activation comprises extension of thepenetrating element of the lancet and retraction of the same into ahousing to provide for safe storage and disposal. In the extendedposition, the penetrating element is adapted to lance, pierce, slice,prick or otherwise penetrate the users finger positioned at point (63).Blood is then collected at blood collection window (54). The receptacleof buffer (55) is then removed from the body and the solution is addedto the blood collection window (54). The lateral flow test strip extendsacross the body (51) at lateral flow test strip (56) allowing results tobe read in the results window (57).

In a third embodiment a diagnostic system (70) comprises a body (71) inthe form of a housing having six sides. The sides are labelled withindicia (72) indicating the order of which the sides are to be used. Auser will initially peel foil (73) from over an alcohol swab and drywipe (74 and 75) which are positioned within an alcohol swab locator inthe form of a depression (76) in one side of the diagnostic system (70).The user will clean their finger with the alcohol swab and then willinsert their finger into finger pad depression (78) on a second side ofthe diagnostic system (70). An integrated lancet (79) is positionedwithin this side and actuated by lancet activator (80). Once the userhas contacted lancet activator (80) the lancet tip extends from the body(71) to pierce a finger in the aperture (78). The lancet tip thenretracts. The user then allows their blood to be collected at bloodcollection window (82) on a third side of the diagnostic system (70).

A solution delivery actuator (84) is positioned on the same side of thediagnostic system (70) as the blood collection window (82). Depressionof the solution delivery actuator delivers a physiologically acceptablesolution or buffer to the lateral flow test strip. The lateral flow teststrip is incorporated into the diagnostic system (70) although it is notvisible from' the outside of the system. The blood collected at bloodcollection window (82) and the buffer solution released upon depressionof solution delivery actuator (84) combine to allow the test strip orother test material to provide results in the results window (86). Theuser then peels an adhesive strip from the adhesive bandage locator (87)located in the fourth side of the system. The adhesive bandage can thenbe used to bandage the pierced finger.

A fourth embodiment is shown in FIGS. 13 to 15. In this embodiment adiagnostic system (100) comprises a body (101) in the form of anelongate housing. The body (101) includes a finger pad aperture (102)which is positioned adjacent a lancet (103). The lancet (103) isintegrated into the body (101) and is moveable between a position inwhich the lancet tip is enclosed within the body (101) and a position inwhich the lancet tip extends from the body into the finger pad aperture(102).

The diagnostic system further comprises a lancet activator (104) whichis actuated to move the lancet between the rest position in which it isenclosed in the body (101) and the actuator position in which it extendsinto the finger pad depression point (102). The reverse side of the body(101) comprises a solution delivery actuator in the form of a pushbutton (106), along with a blood collection window (107) and resultswindow (108).

In use, a user inserts their finger into the finger pad aperture (102)with the finger pad pressing against the integrated lancet (103). Theuser then actuates the lancet (103) by pressing lancet actuator (104).This acts to pierce the finger. The user then collects blood in bloodcollection window (107) and presses solution delivery actuator (106) toallow buffer solution or other physiologically acceptable solution tocontact the blood in blood collection window (107) and the lateral flowtest strip which is incorporated into the diagnostic system. The lateralflow test strip then provides a result at results window (108).

A fifth embodiment of the present diagnostic system is shown in FIGS. 16to 18. In this form the system is in kit form and the support membercomprises a hard cover case (110). The hard cover case is hinged along acentral hinge (111) and opens to reveal a removable lancing system(112), an alcohol swab, and dry wipe locator (113) a blood collectionwindow, (114) a lateral flow test strip, (115) a results window, (116) asolution delivery actuator, (117) and an adhesive bandage locator (118).

In use, a user removes the foil from alcohol swab and dry wipe locator(113) to clean a finger for use. The user then removes the removablelancet (112) from the hard cover case (110) and positions their fingerat the piercing end (118) of the integrated lancet (112). The user thendepresses lancet actuator (119) to pierce the finger.

Blood is collected at blood collection window (114) above test strip(115). A buffer solution reservoir (120) is located in the body and isconnected with the test strip (115) by a channel (121). The user slidessolution delivery actuator (117) forward to direct the buffer to thetest strip and results are provided in the results window (116).

In a sixth embodiment, shown in FIGS. 19 through 21, disclosed is acomposite diagnostic system (140). The diagnostic system 140 may in oneform be hand held.

Alternatively the system may be sized to be utilised as a table topsystem. The diagnostic system (140) comprises a support member (142)which is made up of a body (143) in the form of a housing having anelongated oval shape. The body (143) comprises top face (144) bottomface (145) and sides (146) and extends from a distal end (147) at whichthe lancet is positioned to a proximal end (148).

The diagnostic system further comprises an integrated lancet (149). Theintegrated lancet is positioned in the distal end (147) of the body(143) and is surrounded by the external walls of the body. A lancet tip(151) is positioned in a rest position internally to the body (142). Thelancet tip (151) is positioned to extend from the body (142) when thelancet is actuated. In the actuated position, the lancet tip (151)extends from the body such that a finger positioned at the distal end ispierced by the lancet upon the lancet moving between the rest positionand the actuated position. The lancet tip (151) then retracts into thebody (143).

In use, activation of the lancet between the rest position and theactuated position occurs through depression of a lancet activator (153)which extends from the distal end (147). A user places their fingeragainst a protruding end (155) of the lancet (149) and this contactresults in depression of the lancet activator (153) moving the lancettip (151) to pierce a finger or alternative body part positioned at thedistal end (147).

Upon a users finger being pierced by the lancet, the user or clinicianmoves the user's finger over the fluid collection element (156) which,in the illustrated form, is in the form of a window. Bodily fluid, inthis case blood, is collected at fluid collection element (156). Thefluid collection element (156) is positioned proximal to the distal end(147) to allow a user to easily move the pierced finger to the fluidcollection element (156) without depositing fluid other than in theelement.

While the fluid collection element (156) has been described in the formof a window into which fluid is deposited, the collection element (156)could alternatively be in the form of a capillary tube which may beadapted to retain and deposit quantifiable amounts of fluid, analternate opening or depression, a loop adapted to retain and depositsmall amounts of fluid, a well or any alternative embodiment whichallows for deposit of fluid and transfer or movement or placement ontothe test material within the system.

The diagnostic system further comprises a physiologically acceptablesolution such as a buffer stored in a buffer sachet (159) for supportingthe blood or other bodily fluid. A solution delivery actuator (160) ispositioned on the diagnostic system. Contact with the solution deliveryactuator (160) releases the buffer solution from the sachet (159).

A test material in the form of a test strip (162) is positioned beneaththe buffer sachet (159) and the fluid collection window (156). The testmaterial in the illustrated form comprises a lateral flow test strip,however it may comprise a vertical flow test strip, solid phase testmaterial, agglutination test material, a cartridge or reagent tube orany element which incorporates a reagent adapted to be mixed with thebodily fluid, a card incorporating a fluid sample retention material, anassay, a test strip or an integrated electrical circuit.

The diagnostic system further includes a results window (164) which ispositioned on the same side as the fluid collection window (156) foreasy viewing of the results of any diagnostic test performed.

An alcohol swab locator (165) in the form of indicia or a depression orother location feature in which alcohol swabs and dry wipes can beinserted or attached is positioned in a surface of the support membersuch as in the illustrated form in side (146).

An adhesive bandage locator (167) is positioned in the proximal end(148) of the diagnostic system (140). The adhesive bandage locator is ina form of a slit extending into the body (142) of the system (140) whichfits adhesive bandages such as Band-Aids™.

In a seventh embodiment shown in FIGS. 22 through 26 disclosed is acomposite diagnostic system (140). The diagnostic system (140) comprisesa support member (142) which is made up of a body (143) in the form of ahousing having an elongated oval shape. The body (143) comprises topface (144) bottom face (145) and sides (146) and extends from a distalend (147) at which a lancet is located to a proximal end (148).

The diagnostic system further comprises an integrated lancet (149). Theintegrated lancet is positioned in the distal end (147) of the body(143) and is surrounded by the external walls of the body. A lancet tip(not illustrated in this form) is positioned in a rest positioninternally to the body (142). The lancet tip is positioned to extendfrom the body (142) when the lancet is actuated. In the actuatedposition, the lancet tip extends from the body such that a fingerpositioned at the distal end is pierced by the lancet upon the lancetmoving between the rest position and the actuated position. The lancettip thereafter retracts into the body (143) to allow for safe storage ordisposal of the system.

In use, activation of the lancet between the rest position and theactuated position occurs through depression of a lancet activator (153)which extends from the distal end (147). A user places their fingeragainst a protruding end (155) of the lancet (149) and this contactresults in depression of the lancet activator (153) moving the lancettip to pierce a finger or alternative body part positioned at the distalend (147).

Upon a users finger being pierced by the lancet, the user or clinicianmoves the user's finger over the fluid collection element (156) which,in the illustrated form, is in the form of a window. Bodily fluid, inthis case blood, is collected at fluid collection element (156). Thefluid collection element (156) is positioned proximal to the distal end(147) to allow a user to easily move the pierced finger to the fluidcollection element (156) without depositing fluid other than in theelement. While the fluid collection element (156) has been described inthe form of a window into which fluid is deposited, the collectionelement (156) could alternatively be in the form of a capillary tubewhich may be adapted to retain and deposit quantifiable amounts offluid, an alternate opening or depression, a loop adapted to retain anddeposit small amounts of fluid, a well or any alternative embodimentwhich allows for deposit of fluid and transfer or movement or placementonto a test material.

The diagnostic system further comprises a physiologically acceptablesolution such as a buffer stored in a buffer sachet (159) for supportingthe blood or other bodily fluid. A solution delivery actuator (160) inthe form of a slide is positioned on the diagnostic system. Sliding thesolution delivery actuator (160) into an actuated position (shown inFIGS. 25 and 26) releases the buffer solution from the sachet (159).

A test material in the form of a test strip (162) is positioned beneaththe buffer sachet (159) and the fluid collection window (156). The testmaterial in the illustrated form comprises a lateral flow test striphowever it may alternatively comprise a vertical flow test strip, solidphase test material, agglutination test material, a cartridge or reagenttube or any element which incorporates a reagent adapted to be mixedwith the bodily fluid, a card incorporating a fluid sample retentionmaterial, an assay, a test strip or an integrated electrical circuit.

In one form the test material is adapted to interface with diagnosticequipment to provide a diagnosis. In one form the test material isremovably engaged with the diagnostic system and is adapted upon removalto interface with diagnostic equipment for diagnosis. For example, atest strip may be removable and able to be inserted into diagnosticequipment for analysis. In another form a portion of the system such asa cartridge containing the test material or a fluid retainer isremovable from the system to interface with diagnostic equipment.

Alternatively the system may include a port or platform for engagementwith diagnostic equipment. The port may be in the form of a window oropening in contact with the test material. The diagnostic system canthen interface with diagnostic equipment to be analysed and provide adiagnosis.

The diagnostic system further includes a results window (164) which ispositioned on the same side as the fluid collection window (156) foreasy viewing of the results of any diagnostic test performed. Theresults window (164) in this embodiment is positioned under the solutiondelivery actuator (160) when it is in a rest position (shown in FIGS. 22and 23) and is revealed when the solution delivery actuator (160) is inan actuated position (shown in FIGS. 25 and 26). In the actuatedposition the fluid collection window (156) is covered by the solutiondelivery actuator (160).

An alcohol swab locator (165) in the form of a depression in whichalcohol swabs and dry wipes can be inserted is positioned on the topface (144).

An adhesive bandage locator (167) is positioned in the distal end (148)of the diagnostic system (140). The adhesive bandage locator is in aform of a slit extending into the body (142) of the system (140) whichfits adhesive bandages such as Band-Aids™.

FIGS. 27 through 29 show an eighth embodiment of a diagnostic system.The diagnostic system (180) comprises a body (181) composed of asampling section (183) and a diagnostic section (184). The samplingsection (183) and the diagnostic section (184) are removably engagedwith one another. In the illustrated form the diagnostic section (184)caps the sampling section (183) and is engaged by means of a connector,clip, interference fit, snap fit or other engagement method.

The sampling section (183) comprises a sampling body (186). The samplingbody (186) is adapted to be held in one hand, although the body (186)could alternatively be rested on a surface. A membrane penetrationelement (not illustrated in this form) in the form of a lancet islargely enclosed in the body (186). A lancet tip (not illustrated) ispositioned to extend from the body through a lancet opening (187) in anactuated position and retract back into the body thereafter. Actuationof the lancet occurs through pressure on a lancet actuation element(188).

In the illustrated form the membrane penetration element has beendescribed in terms of a lancet, however any other piercing, pricking,slicing, or otherwise penetrating element may be utilised. Of course,the present invention may be applied in contexts where no such piercingelement is required, for example urine testing.

The sampling section (183) further includes a fluid collection element(190). In the illustrated form the fluid collection element (190) is inthe form of a loop (191) although the fluid collection element maycomprise a well, window, capillary tube or any alternative element forfluid collection.

A user positions a body part such as a finger adjacent the lancetopening (187) and actuates the lancet through pressure on the lancetactuation element (188). The lancet penetrates a membrane on the bodypart releasing a fluid, in this case blood. The user positions the bodypart in contact with the loop (191) and deposits a sample of bloodtherein.

The diagnostic section (184) comprises a body (193) which in this formis placed on a surface. The body includes a fluid deposit opening (194)into which the fluid collection element (190) on the sampling section(183) can be inserted to deposit fluid from the loop (191). A testmaterial (not illustrated) is positioned within the body (193) such thatfluid from the sampling section (183) interacts with the test material.In the illustrated form the test material is in the form of anintegrated lateral flow test strip, test strip, cassette, cartridge,integrated circuit or other diagnostic or pre-diagnostic element.

The diagnostic section (184) further includes a test result window (196)through which results of a diagnostic test can be displayed. Theillustrated form shows an integrated test material resulting in anon-site diagnosis, however a person skilled in the art will be awarethat the test material could be adapted to be analyzed elsewhere and adiagnosis provided by separate diagnostic equipment.

As shown best in the first and third embodiments, indicia (72) areincorporated onto the system to visibly cue a user to perform a sequenceof steps in order. In the illustrated embodiment the indicia are in theform of numbers, however it will be clear that graphic, pictorial, textor alternative indicia could effectively present the sequence of stepsto cue a user. In the first embodiment, the indicia (72) instruct theuser to first perform the step on the side labelled “1”, that is, cleanand dry the area of skin in preparation for lancing. The user thenrotates the system to find step “2”, in which the user inserts a fingerinto the finger pad aperture (29) for lancing. The user then activatesthe lancet (28). The user rotates the system to find step “3” in whichthe user deposits blood at the blood collection window (32). Thephysiologically acceptable solution and blood contact the test materialand the results show in the results window on the front face. The userthen rotates the system to perform step 4, placing an adhesive bandageon the finger.

In the third embodiment the steps are much the same, however the step ofdelivering physiologically acceptable solution to the test material isperformed by actuating an actuator (84) positioned adjacent the bloodcollection window (82). In one not illustrated form, a detachablepatient information card or label is affixed to the support member.

In one not illustrated form, the diagnostic system is modular,comprising a body incorporating the membrane penetration element and acartridge, the cartridge incorporating the fluid collection element andtest material and, in some forms, a physiologically acceptable solutionsuch as a buffer and a test results window. In this form, manufacturecomprises separately manufacturing the body incorporating, for example,a lancet and the cartridge. Separate manufacture allows selection ofspecific cartridges for use in a given order.

It will be appreciated that while the embodiments described envisage anintegrated lancet, the present invention could be implemented using aseparate lancet device or other membrane penetration device, or using afluid which is directly sampled of discharged from another device (e.g.a syringe). For example, in a point of care situation, it may be moreconvenient for staff to use conventional disposable lancets with a testunit according to the present invention.

Similarly, the term buffer is used broadly, and is intended to coverboth fluids that are strictly buffer fluids, as well as any fluidrequired to be dispensed before or after the sample is applied to thetest component. The fluid may be any kind of fluid which is used tofacilitate, activate, optimise or otherwise be sued with the test. Itmay be a, in some cases, a simple aqueous solution to reduce theviscosity of a blood sample to assist with chromatography. It may be asimple diluent or running buffer, or a more complex fluid with specificcomponents o properties to make the test component perform better, or atall. The present invention is applicable to any type of fluid that isrequired to be added before, during or after the test sample is applied.

FIGS. 30 to 34 illustrate a further embodiment of the present invention.FIG. 30 show the test unit 200 including a button 203 for release ofbuffer, a fluid collection tube 202, and a lancet component 201.

FIG. 31 illustrates the unit in a partly disassembled form. The tophousing 210 includes the push button 203. In the lower housing 220,beneath the button 203 in the assembled state, is a sachet 230 of abuffer solution. It will be appreciated that this fluid could be anysuitable fluid required to assist the test process, and the term bufferis used for convenience only.

Buffer sachet 330 sits on the lower housing 220 adjacent to the teststrip 221. As can be better seen in FIG. 32, buffer sachet 230 rests ona platform 224, which includes location bosses 222, 223. These serve toassist in locating buffer sachet 230 in the correct position duringmanufacture.

FIG. 33 illustrates the assembled test unit, and in particular theportion associated with buffer sachet 230 and test strip 221. Buffersachet 230 can be seen in position underneath button 203.

In FIG. 34, fluid collection tube 202 has been moved into the dischargeposition, so that the collected fluid is discharged onto the test strip.As the buffer solution is now required, button 203 is depressed. Buffersachet 230 is compressed and the fluid forced out, to release point 226.The buffer solution (not shown) is contained by the side walls 227, sothat it is taken up by the test strip.

It will be appreciated that a particular advantage of this arrangementis that a carefully controlled volume of buffer is provided to the teststrip, allowing for accurate, error free application relative to priorart techniques.

Sachet 230 may be formed from any suitable impervious material, formed(for example by heat or RF welding) into a filled fluid enclosure, butdesigned to rupture under the correct level of force.

FIGS. 35 and 36 illustrate another implementation, particularly inrelation to the construction of the buffer reservoir. In thisarrangement, the buffer is in a concertina type reservoir, formed forexample by blow moulding. Buffer reservoir 254 is located under theupper housing 254 of the test unit 250. The top of the buffer reservoir254 is exposed, and can be depressed, as illustrated by the arrow inFIG. 36. This releases buffer fluid through a directed opening 257 ontothe test strip 256. Again, the fluid collection tube 255 has been movedinto the discharge position and the fluid released prior to the bufferbeing discharged.

It will be appreciated that although the examples provided have been inthe more usual situation where the buffer or other fluid is appliedafter the sample is placed onto the test strip, this is not a specificmechanical limitation of the device. The buffer could be applied, ifappropriate to the test, before the sample is discharged. Alternatively,if the fluid was required to be applied in advance to the strip, forexample in order to activate it, this can be readily accomplished usingthe fluid reservoir of the present invention. The potential foraccurate, controlled dispensing which is provided by the implementationsof the present invention may provide such additional options fordesigning and undertaking tests.

FIGS. 37 and 38 illustrate another implementation of the buffer sachet.In this example, sachet 260 includes a housing 262 and a lower membrane261. It can be seen that the reservoir 263 so formed tapers towards end269. The seal between the housing 262 and lower membrane 261 provides aperipheral flange 268 around sachet 260.

The housing may be formed from any suitable material, having regard tothe operational requirement to bond or seal, retain the selected bufferfluid, to need to provide stability, and reliability at the point whenbuffer discharge is required. A suitable material for housing 262 andmembrane 261 may be a polymer such as PET, or a multilayer aluminium andpolymer material.

The precise dimensions of the sachet will be determined in part by thevolume of fluid required to be dispensed. For a dispensed volume offluid of 80 μm, the sachet of the general shape shown in FIG. 37 mayhave an overall length of about 13 mm, a width of about 10 mm, with thehousing having a width of about 3 mm at end 269. It will be appreciatedthat in any practical system, some of the fluid will be retained in thesachet even after release, and so allowance (e.g. as overfill) for thismust be made in the filled volume. The seal is preferably a double sealaround the periphery, apart from a small section, illustratively at end269, which is single sealed, so that the fluid will preferentiallydischarge at that end when pressure is applied to the sachet.

FIG. 38 illustrates one approach to forming sachet 230 as shown in FIG.37. The housing 262 is shown inverted relative to FIG. 37. Reservoir 263is filled with the buffer solution. Lower membrane 261 is then placedinto position and heat sealed to housing 262. It will be appreciate thatthe general approach to forming and filling such sachets is a wellpracticed art in medical, food preparation and related fields, and thatsuch sachets can be readily manufactured in this way in considerablevolumes.

FIG. 39 illustrates the assembly of the illustrative sachet into a testunit. The test unit includes a test strip plate 270. Test strip 221 islocated correctly into test strip plate 270. Buffer sachet 260 is thenlocated into test strip plate 270, in this implementation partlyoverlying test strip 221. Finally, the top housing 271, which includesthe button 274 which operative depresses buffer sachet 260, is locatedover the completed test strip plate assembly. The assembled componentscan be seen in FIG. 40.

FIG. 41 illustrates, partly in section, the operation of buffer sachet260 and the associated mechanism in this implementation. A compressiveforce is first applied to button 274, which may be illustratively 5N. Itwill be appreciated that the required force is largely a consequence ofthe construction of buffer sachet 260. A balance between ease of use, bynot requiring an excessive force, and accuracy and reliability instorage and preparation, which require the force for release to not betoo small, is required.

The button compresses buffer sachet 260. Once the internal pressure issufficiently high, the single seal region of sachet 260, adjacent to end269, ruptures. This releases the contained buffer at the release point268, onto the test strip 221.

It will be understood that there are many possible alternativesimplementations to achieve the desired controlled release of the bufferfluid. For example, instead of a weakened seal region, the mechanismcould employ a blade or sharpened projection to pierce the buffersachet. The sachet may have a frangible or weakened portion which is notthe seal. The sachet may include a valve, which releases fluid undersufficient pressure. The mechanism for compressing the buffer sachet,instead of being of lever or button type, could operate by sliding orrotation. Suitable channel or tube means could be used to guide therelease buffer fluid to the intended location. The compression mechanismcould be associated with another component of the integrated test unit,for example be engaged by a specific movement or release of the a fluidcollection component.

In one implementation, shown in FIGS. 42 to 45, an interlock is providedto further assist the user in correct operation of the test unit. Theprinciple is that until the lancet has been activated, the bloodcollection unit cannot be moved into the delivery position, and thatuntil the blood collection unit has been moved into the deliveryposition, the buffer cannot be released. It will be understood that if,for example, it was required that a test fluid be dispensed to the testcomponent before the sample was delivered to the test component,comparable interlock mechanisms could be used.

FIG. 42 illustrates one end of test unit 280. In FIGS. 42 and 43, thetop housing is not shown, to better facilitate understanding. It will beunderstood that this drawing is intended to particularly illustrate oneimplementation of an interlock. This approach may be applied to othersuitable implementations described above. Moreover, the interlock may beapplied only in part, for example to ensure buffer release after sampledelivery in an implementation without an integral lancet device.

FIG. 42 shows the lancet assembly 281, with a sleeve 282 extending tospring 287. A shelf 286 extends along the side of sleeve 282. Bloodcollection arm 283 carries a capillary 288 for collecting a sample ofblood. Blood collection arm 283 is rotatable about an axis, generallyindicated as 284, in order to deliver the blood in capillary 288 to atest strip (not shown in this view).

However, in the state shown in FIG. 42, shelf 286 engages projection285, thereby preventing rotation of the blood collection arm 283. Thus,rotation is prevented until the lancet has been operated.

FIG. 43 is a similar view to FIG. 42, but the lancet has been operated.The sleeve 282 has now moved longitudinally and compressed spring 287.Shelf 286 is accordingly moved forward, so that it no longer engagesprojection 285. Thus, blood collection arm 283 is able to rotate.

The same projection 285 is important in preventing release of the testfluid in this implementation, until the blood collection arm is rotatedto the delivery position. This can be seen in FIG. 44. The top housing290 can now be seen, including button 292. The recess 291 for deliveryof the sample, and a part of the test strip 295 can also be seen.

In the position of FIG. 44, projection 285 on blood collection arm 283engages foot 293 which extends from the top housing. Whilst foot 293 isengaged, the button 292 cannot be depressed, and hence the buffer sachet(not shown) cannot be depressed and the fluid released. Buffer releasein this example is closely related to the mechanism in FIG. 41.

FIG. 45 illustrates the situation once the blood collection arm 283 hasbeen rotated to the delivery position. The capillary 288 engages thetest strip 295 and releases the blood sample. The projection 285 has nowrotated to a position where it does not engage foot 293, and so button292 can be depressed, so as to release the test fluid.

Whilst the illustrated examples provide a single fluid, the presentinvention could be implemented so that more than one reservoir of fluidis released, either by a single action, or by operating two differentbuttons or the like. The test may require one or other fluid to be used,depending for example upon some characteristic of the test required orof the individual providing the fluid sample.

1. An integrated testing device comprising: a test component; areservoir adapted to contain a test fluid; and a fluid deliveryactuator, wherein operation of the fluid delivery actuator causes thetest fluid to be released from the reservoir so as to contact the testcomponent.
 2. An integrated testing device according to claim 1, whereinthe device further includes a receptacle for receiving a bodily fluid,so that the bodily fluid contacts or can be caused to contact the testcomponent.
 3. An integrated testing device according to claim 2, whereinthe actuator is adapted to be manually operated.
 4. An integratedtesting device according to claim 1, wherein an interlock prevents therelease of the test fluid until a specific stage in the test process. 5.An integrated testing device according to claim 4, wherein an interlockprevents the release of the test fluid until the bodily fluid hascontacted the test component.
 6. An integrated testing device accordingto claim 1, wherein the test component is removable from the diagnosticsystem.
 7. An integrated testing device according to claim 1, whereinthe actuator is adapted to enable the release a controlled amount oftest fluid.
 8. An integrated testing device according to claim 1,wherein the device comprises a plurality of reservoirs adapted tocontain test fluids.
 9. An integrated testing device according to claim1, wherein the or each reservoir is a separately formed sachet.
 10. Anintegrated testing device according to claim 9, wherein the sachet isformed so that when pressure is applied by the actuator, test fluid isemitted from a specific site on the sachet.
 11. Am integrated testingdevice according to claim 10, wherein the actuator comprises a buttonlocated on the housing of the device.
 12. An integrated testing device,comprising a support structure, a reservoir adapted to contain a testfluid, and a fluid delivery actuator, the device being adapted toreceive a test component in said support structure, so that operatively,once a test component is received, the fluid delivery actuator canselectively causes the test fluid to be released from the reservoir soas to contact the test component.
 13. An integrated testing deviceaccording to claim 12, wherein the reservoir is a separately formedsachet, and contains a test fluid appropriate from the test component.14. An integrated testing device according to claim 14, wherein thesachet is formed so that when pressure is applied by the fluid deliveryactuator, the test fluid is emitted from a specific site on the sachet.15. A method for conducting a test on a sample of a bodily fluid,comprising the steps of providing a testing device including a reservoircontaining a test fluid, and further including a test component, whereina sample of the bodily fluid is placed on the test component, and aquantity of test fluid is discharged from said reservoir onto the testcomponent, the discharge being either before or after the sample isplaced on the test component, so that the test component can therebyconduct the test.